The Impact of Outcomes
Rodney A. White, MD, discusses the goals of the SVS Outcomes Committee, issues in reimbursement, and assessments of high-risk patient outcomes data.
Endovascular Today: What are the goals of the Society for Vascular Surgery (SVS) Outcomes Committee?
Dr. White: The goal of the committee is to establish standards for and endovascular interventions and conventional surgical procedures in all vascular beds with the goal of being able to enhance reporting and assess procedural outcomes.
Endovascular Today: What is your role on the Outcomes Committee?
Dr. White: I am a member of the Outcomes Committee, and I was originally the Chairman of the Lifeline Registry Steering Committee, which collected and reported the PMA-approved datasets from the US aneurysm trials. I was also involved in the second phase, which was the carotid registry. Now, this effort is evolving into a global outcomes assessment initiative, as best as we can accomplish that. Our attempt is to collaborate with everyone involved in performing either conventional surgical or endovascular procedures, which means working with other societies and subspecialties, particularly the American College of Cardiology and The Society of Interventional Radiology, and then also with the agencies that are involved with the approval and reimbursement of devices and procedures–the FDA and CMS. Another agency we're working with is the Agency for Healthcare Research and Quality (AHRQ), which supports research aimed at improving the quality of our healthcare offering. The role of AHRQ is going to be increasingly important for interventionists because CMS has designated that reimbursement is going to be tied to outcomes in the next several years, and AHRQ is in the process of conducting studies and generating documents that directly relate to outcomes assessment, and then making recommendations based on that.
Endovascular Today: What are some of the challenges that the Outcomes Committee is currently facing?
Dr. White: One of the challenges is to try to decide which are the appropriate outcomes data that need to be collected in order to allow us to do the best analyses pertaining to what yields the best patient outcomes. Secondarily, we need to do that in a cost-effective perspective; any time data need to be entered, it's a labor-intensive process involving a number of steps, such as retrieval mechanisms, auditing processes, and regulatory overlays. All of this is tied to CMS's requirement for registry data for carotid stenting and their desire to link payment to procedural outcomes analysis. It is a way not only to address the patient care issue, but also payment, and CMS is also looking at using it to determine site approvals and potentially even recertification for privileging. It then extends logically to outcomes for all vascular procedures, and the SVS is in a unique position in that we do both open and endovascular procedures and we have a history of being the primary vascular caregivers.
Endovascular Today: What is the Outcomes Committee doing as far as circulating the data it is collecting?
Dr. White: We are in cooperation and collaboration with the various government agencies, and we have attempted to make our data available to all of the agencies, and particularly to AHRQ because we feel that the data we have are valuable with respect to what these agencies are charged with doing–making decisions regarding the best practices for patient treatment. For example, we are currently publishing an analysis of the high-risk patient data from the US IDE trials of endovascular abdominal aortic aneurysm devices, using similar definitions as were used to distinguish the "unfit" patient populations in the EVAR-1 and EVAR-2 studies.
The purpose of this collation and examination of high-risk patient data is to address the concerns expressed by AHRQ regarding the high morbidity and mortality seen in the EVAR-2 outcomes, which was reported at 9%. We feel this number is excessive, and in the US IDE dataset, it was approximately 2.5% to 3%, which we see as a very different and more acceptable rate. Our intent is to make these data available to assist in deciding upon the standards of care and appropriate payments. We think these data are the ideal basis for making these decisions because they have been initially independently audited as part of FDA-sanctioned studies, in which each individual patient record and outcome is assessed in great detail.
Endovascular Today: Without this scrutiny and publication of the US IDE data, was AHRQ ready to make its reimbursement decision for high-risk patients based on non-US data?
Dr. White: Our understanding was that there was a document prepared by AHRQ, which was publicly circulated for comment, that did make certain conclusion based on EVAR-2. Based upon what a number of physicians and groups submitted in response, however, that document has been revised. We do not know when the revised document will be published or what it will say. The agency's intention was to solicit input and to wait to make a decision until it had heard back, as long as it was within a certain timeframe, which we were able to accomplish.
Endovascular Today: What are your opinions on the conclusions of the EVAR-2 trial?
Dr. White: The data from this trial have been looked at extensively as flawed from several perspectives. The first is the randomization model and the delay in treatment. Half of the patients in the endovascular arm were delayed up to 60 days after randomization before they were treated, and half of the mortality rate reported was in that group, probably due to the delay in treatment. In my opinion, even if high-risk patients are being studied, if they have anatomy amenable to treatment, then they should be treated without delay, as was evidenced by these data. The other criticisms that could be offered–and this is somewhat controversial–in the US environment, because of the nature of aneurysmal disease, we found that randomization is not a good model for this type of study. Our clinical studies have evolved away from it, with even some institutional review boards considering that offering a patient a less-invasive method and then randomizing them to even conventional surgery is not even ethical. So there are ethical considerations, statistical problems, and my opinion is that this type of randomization is neither possible nor useful anymore, and that newer models that have evolved are much safer and more useful. These models have come from a lot of time and effort put forth by the FDA over more than 15 years and across a wide experience with many studies.
Endovascular Today: In that same light, with respect to the morbidity and mortality data, would you say that today's outcomes are quite possibly even better than the acceptable numbers was seen in the US IDE studies, for reasons such as device improvement and better understanding of both technique and disease?
Dr. White: I think that's correct; in fact, when you're looking historically at technology that has evolved over the last 10 to 15 years, and we have a window of some 5 to 7 years ago, with all of the rapid evolution that has occurred and the indications that evolved, our impression is that it continues to improve. That's the whole point in doing quality assessment in an ongoing matter. The datasets that we're looking at from 5 to 7 years ago in the registry data provide very acceptable outcomes for patients that none of us are ashamed of using even as today's standards.
Endovascular Today: Should a US reimbursement decision for any procedure or patient population be based, in part or in whole on a non-US study?
Dr. White: Although it is important to do an academic review of all data that has been reported, regardless of where the data are collected, I do not think that US reimbursement should be based on non-US outcomes. The European EVAR studies have been the only source of randomized or what's considered "high-level" data for some time now, but our view is that the way the FDA studies have evolved and the IDE data were collected with a high level of compliance and reporting, that their data are of a comparable level to randomized studies. Further, because it is a US dataset, it should be the primary, if not the sole, source of information used to determine US recommendations for reimbursement. From an overall standpoint, the health care patterns, the availability of procedures and technology, and even the expectations of the consumers are totally different from country to country. The health care systems function differently, and the data derived from them should be viewed in their own contexts.
Endovascular Today: Based on your own clinical experiences, how should high-risk AAA patients be treated?
Dr. White: The primary indication in the US is to use endovascular technology for high-risk patients who are not candidates for other procedures if their anatomy is so suited. Our institution's data is one of the largest contributors to the US IDE data, and from what we've seen, the data speak for themselves–the patients do very well when treated endovascularly.
Endovascular Today: In your opinion, how should reimbursement for high-risk AAA patients undergoing endovascular care be structured?
Dr. White: Based on the data we have in the US, whether in the high-risk, low-risk, or the various subcategories we have outcomes data in, I think endovascular repair in these patients is justified and should be reimbursed. I think we have a very sound dataset that supports reimbursement for all patients that have the appropriate anatomy.
Rodney A. White, MD, is Professor of Surgery, UCLA School of Medicine, and is Chief of Vascular Surgery and Associate Chairman of the Department of Surgery at Harbor-UCLA Medical Center, Torrance, California. Dr. White may be reached at email@example.com.